A prospective, randomized trial of tacrolimus/prednisone versus tacrolimus/prednisone/mycophenolate mofetil in renal transplant recipients

Background. Between September 20, 1995 and September 20, 1997, 208 adult patients undergoing renal transplantation were randomized to receive tacrolimus/prednisone (n=106) or tacrolimus/prednisone/mycophenolate mofetil (n=102), with the goal of reducing the incidence of rejection. Methods. The mean recipient age was 50.7±13.7 years. Sixty-three (30.3%) patients were 60 years of age or older at the time of transplantation. The mean donor age was 34.5±21.7 years. The mean cold ischemia time was 30.5±9.2 hr. The mean follow-up is 15±7 months. Results. The overall 1-year actuarial patient survival was 94%; the overall 1-year actuarial graft survival was 87%. When the patient and graft survival data were stratified to recipients under the age of 60 who did not have delayed graft function, the overall 1-year actuarial patient survival was 97%, and the corresponding 1-year actuarial graft survival was 93%. There were no differences between the two groups. The overall incidence of rejection was 36%; in the double-therapy group, it was 44%, whereas in the triple therapy group, it was 27% (P=0.014). The mean serum creatinine was 1.6±0.8 mg/dL A total of 36% of the successfully transplanted patients were taken off prednisone; 32% of the patients were taken off antihypertensive medications. The incidence of delayed graft function was 21%, the incidence of cytomegalovirus was 12.5%, and the initial and final incidences of posttransplant insulin-dependent diabetes mellitus were 7.0% and 2.9%; again, there was no difference between the two groups. Conclusions. This trial suggests that the combination of tacrolimus, steroids, and mycophenolate mofetil is associated with excellent patient and graft survival and a lower incidence of rejection than the combination of tacrolimus and steroids

Heart transplantation for Chagas cardiomyopathy in the United States.

Since an initial case in 2006, we noted multiple patients undergoing heart transplantation (HTx) for Chagas cardiomyopathy (CC) at our transplant program. The clinical characteristics, laboratory results and outcomes of patients with CC undergoing HTx in the United States have not been reported previously. In 2010, we implemented a systematic screening and management program for patients undergoing HTx for CC. Before HTx, all patients with idiopathic dilated cardiomyopathy who were born in a Chagas disease endemic country were screened for Trypanosoma cruzi (TC) infection with serology. After HTx, monitoring for TC reactivation was performed using clinical visits, echocardiography, endomyocardial biopsy and serial whole blood polymerase chain reaction (PCR) testing. Between June 2006 and January 2012, 11 patients underwent HTx for CC. One patient was empirically treated due to the presence of TC amastigotes in explanted cardiac tissue. Two patients experienced allograft dysfunction due to TC reactivation and three patients experienced subclinical reactivation (positive PCR results), which were treated. Chagas disease is a common cause of dilated cardiomyopathy in patients from endemic countries undergoing HTx at a transplant program in the United States. Reactivation is common after transplantation and can cause adverse outcomes

Confirmation of the safety of autologous blood donation by patients awaiting heart or lung transplantation: A controlled study using hemodynamic monitoring

AbstractBackground: Though earlier investigations have demonstrated the efficacy of autologous blood transfusion in reducing allogeneic blood exposure in patients undergoing heart or lung transplantation, questions remain regarding the safety of blood donation by patients with severe heart or lung disease. Methods: Response to autologous blood donation by candidates for heart and lung transplantation and a group of age- and gender-matched control subjects was studied. Heart rate, blood pressure, oxygen saturation, and cardiac rhythm were examined before and after phlebotomy, and response to orthostatic challenge was evaluated. Patients were also questioned regarding impressions of changes in subjective sense of well being. Differences between patients and control subjects were evaluated by the paired t test and Fisher's exact test. An alpha of 0.05 was used in all testing to determine statistical significance. Results: Eighteen candidates for heart transplantation, 16 candidates for lung transplantation, and their matched control subjects were studied. Though patients and control subjects differed with respect to baseline hemodynamic measurements, significant differences between the groups' responses to phlebotomy were not observed. After whole blood donation, orthostatic challenge resulted in a mean change in mean arterial pressure of -2.1 mm Hg in candidates for heart transplantation compared with a mean of +3.6 mm Hg in their control subjects (p = 0.062). In candidates for lung transplantation there was a mean change of +2.2 mm Hg after orthostatic challenge versus a mean change of +8.5 mm Hg in their control subjects (p = 0.052). Furthermore, no changes in cardiac rhythm or arterial oxygen saturation were detected. Conclusions: The hemodynamic effects of autologous blood donation in a group of patients with significant cardiac or pulmonary disease were not different from those observed in patients considered acceptable candidates for autologous blood collection. On the basis of these objective findings, we believe that patients with less severe degrees of heart or lung disease should not be excluded from participation in autologous blood donation programs. (J T HORAC CARDIOVASC SURG 1995;110:1594-9